Pilesia

Patient Information Leaflet

Pilesia 2 mg film-coated tablets, 4 mg film-coated tablets, 6 mg film-coated tablets, 8 mg film-coated tablets, 10 mg film-coated tablets, 12 mg film-coated tablets

perampanel
Equivalent medicine
Please read this leaflet carefully before taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Pilesia is and what it is used for
2. What you need to know before taking Pilesia
3. How to take Pilesia
4. Possible side effects
5. How to store Pilesia
6. Contents of the pack and other information

1. What Pilesia is and what it is used for

Pilesia contains an active substance called perampanel. It belongs to a group of medicines known as antiepileptics. These medicines are used to treat epilepsy, a condition in which a person has repeated seizures (epileptic seizures). Your doctor has prescribed it to you to reduce the number of epileptic seizures.
Pilesia is used in combination with other antiepileptic medicines for the treatment of certain types of epilepsy:
In adults, adolescents (aged 12 years and older), and children (aged between 4 and 11 years):

• It is used to treat epileptic seizures affecting one part of the brain (called "partial seizures").
• These partial seizures may or may not be followed by a seizure affecting the entire brain (called "secondary generalization"). In adults, adolescents (aged 12 years and older), and children (aged between 7 and 11 years)
• It is also used to treat certain epileptic seizures that affect the entire brain from the start (called "generalized seizures") and that cause convulsions or absence seizures.

2. What you need to know before taking Pilesia

DO NOT TAKE Pilesia:

• if you have ever developed a severe skin rash or skin peeling, blistering and/or mouth ulcers after taking perampanel.
• if you are allergic to perampanel or to any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions
Talk to your doctor or pharmacist before taking Pilesia if you have liver problems or moderate to severe kidney problems.
You must not take Pilesia if you have severe liver problems or moderate to severe kidney problems.
Before taking this medicine, inform your doctor if you have previously had problems with alcoholism or drug dependence.
Cases of increased liver enzymes have been reported in some patients taking perampanel in combination with other antiepileptic drugs.

• Pilesia may cause dizziness or drowsiness, especially at the beginning of treatment.
• Pilesia may increase the risk of falls, particularly in elderly people; this may be due to the underlying disease.
• Pilesia may cause aggression, anger or violence. It may also cause unusual or extreme changes in behaviour or mood, abnormal thoughts and/or loss of contact with reality. If you or a family member or friend notice any of these reactions, consult your doctor or pharmacist.

A small number of people treated with antiepileptic medicines have had thoughts about harming themselves or suicide. If at any time you have such thoughts, contact your doctor immediately.
Serious skin reactions have been reported with the use of perampanel, including drug reaction with eosinophilia and systemic symptoms (DRESS) and Stevens-Johnson syndrome (SJS).

• DRESS usually presents, although not exclusively, with flu-like symptoms and a rash accompanied by high body temperature, increased levels of liver enzymes found in blood tests, an increase in a type of white blood cells (eosinophilia), and swollen lymph nodes.
• Stevens-Johnson syndrome (SJS) may initially appear as red spots ("target" lesions) or circular patches, often with central blisters, located on the trunk. In addition, ulcers in the mouth, throat, nose, genitals and eyes (red and swollen eyes) may occur. These serious skin rashes are often preceded by fever and/or flu-like symptoms. Skin rashes may progress to widespread peeling and potentially life-threatening complications, or may be fatal.

If any of the above conditions occur after taking Pilesia (or if in doubt), consult your doctor or pharmacist.
Children
Pilesia is not recommended for children under 4 years of age. Safety and efficacy have not yet been established in children under 4 years of age for partial seizures and under 7 years of age for generalized seizures.
Other medicines and Pilesia
Inform your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including those without a prescription and herbal medicines. Taking Pilesia with certain other medicines may cause side effects or affect their action. Do not start or stop treatment with other medicines without consulting your doctor or pharmacist.

• Other antiepileptic medicines such as carbamazepine, oxcarbazepine and phenytoin, used to treat epileptic seizures, may affect Pilesia. Inform your doctor if you are taking or have recently taken these medicines, as your dose may need to be adjusted.
• Felbamate (a medicine used to treat epilepsy) may also affect Pilesia. Inform your doctor if you are taking or have recently taken this medicine, as your dose may need to be adjusted.
• Midazolam (a medicine used to stop prolonged acute (sudden) seizures, for sedation and for sleep problems) may be affected by Pilesia. Inform your doctor if you are taking midazolam, as your dose may need to be adjusted.
• Other medicines such as rifampicin (a medicine used to treat bacterial infections), St. John’s wort (a herbal medicine used to treat mild anxiety) and ketoconazole (a medicine used to treat fungal infections) may affect Pilesia. Inform your doctor if you are taking or have recently taken these medicines, as your dose may need to be adjusted.
• Hormonal contraceptives (including oral contraceptives, implants, injections and patches). Inform your doctor if you are taking hormonal contraceptives. Pilesia may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Pilesia, you must use other effective and reliable contraceptive methods (such as condoms or an intrauterine device) and continue using them for one month after stopping treatment. Discuss with your doctor the most suitable contraceptive method for you.

Pilesia and alcohol
Consult your doctor before drinking alcohol. Be cautious about alcohol consumption when taking antiepileptic medicines, including Pilesia.

• Drinking alcohol during treatment with Pilesia may reduce your level of alertness and affect your ability to drive or operate tools or machinery.
• Drinking alcohol during treatment with Pilesia may also worsen possible feelings of anger, confusion or sadness.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, ask your doctor for advice before taking this medicine. Do not stop treatment without first discussing it with your doctor.

• Pilesia is not recommended during pregnancy.
• To avoid becoming pregnant during treatment with Pilesia, you must use a reliable method of contraception and continue using it for one month after stopping treatment. Inform your doctor if you are taking hormonal contraceptives. Pilesia may reduce the effectiveness of certain hormonal contraceptives, such as levonorgestrel. During treatment with Pilesia, you must use other effective and safe contraceptive methods (such as condoms or an intrauterine device) and continue using them for one month after stopping treatment. Discuss with your doctor the most suitable contraceptive method for you. It is not known whether the active ingredient of Pilesia passes into breast milk. Your doctor will assess the benefits and risks to the baby if treatment with Pilesia is needed during breastfeeding.

Driving and using machines
Do not drive or operate machinery until you are certain how Pilesia affects you. Talk to your doctor about the effects of epilepsy on driving and operating machinery.

• Pilesia may cause dizziness or drowsiness, especially at the beginning of treatment. If this occurs, do not drive and do not use tools or machinery.
• Drinking alcohol during treatment with Pilesia may worsen these effects.

Pilesia contains lactose
Pilesia contains lactose. If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Pilesia

Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.
Dosage
Adults and adolescents (aged 12 years and older) for the treatment of partial seizures and generalized seizures:
The usual starting dose is 2 mg once daily before bedtime.

• Your doctor may increase this dose in increments of 2 mg, up to a maintenance dose ranging from 4 mg to 12 mg, depending on your response to treatment.
• If you have mild to moderate liver problems, the dose should not exceed 8 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by your doctor. It may take several weeks to find the appropriate perampanel dose for you.

The table below summarizes the recommended doses for the treatment of partial seizures in children aged between 4 and 11 years, and generalized seizures in children aged between 7 and 11 years. Further details are provided below the table.

Children (aged 4 to 11 years) weighing at least 30 kg or more in the treatment of partial seizures:
The usual initial dose is 2 mg once daily before bedtime.

• The doctor may increase this dose in increments of 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on the response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

Children (aged 4 to 11 years) weighing between 20 kg and less than 30 kg in the treatment of partial seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on the response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

Children (aged 4 to 11 years) weighing less than 20 kg in the treatment of partial seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on the response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

Children (aged 7 to 11 years) weighing at least 30 kg in the treatment of generalized seizures:
The usual initial dose is 2 mg once daily before bedtime.

• The doctor may increase this dose in increments of 2 mg, up to a maintenance dose between 4 mg and 8 mg, depending on the response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 12 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

Children (aged 7 to 11 years) weighing between 20 kg and less than 30 kg in the treatment of generalized seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 4 mg and 6 mg, depending on the response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 8 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

Children (aged 7 to 11 years) weighing less than 20 kg in the treatment of generalized seizures:
The usual initial dose is 1 mg once daily before bedtime.

• The doctor may increase this dose in increments of 1 mg, up to a maintenance dose between 2 mg and 4 mg, depending on the response to treatment. Depending on individual clinical response and tolerability, the dose may be increased up to a maximum dose of 6 mg/day.
• If the child has mild or moderate liver problems, the dose must not exceed 4 mg per day, and dose increases should be made at intervals of at least 2 weeks.
• Do not take a dose of Pilesia higher than that recommended by the doctor. It may take several weeks to find the appropriate perampanel dose for the child.

How to take Pilesia
Pilesia is for oral use.
The tablet should be swallowed whole with a glass of water. You may take Pilesia with or without food. Do not chew, crush, or divide the tablet. The tablets cannot be accurately divided because they do not have a score line.

If you take more Pilesia than you should
If you have taken more Pilesia than you should, contact your doctor immediately. Symptoms such as confusion, agitation, aggressive behaviour, and reduced level of consciousness may occur.

If you forget to take Pilesia

• If you forget to take a tablet, wait until your next scheduled dose and then continue as usual.
• Do not take a double dose to make up for the missed dose.
• If you have missed less than 7 days of Pilesia treatment, continue taking the daily tablet according to your doctor's initial instructions.
• If you have missed more than 7 days of Pilesia treatment, inform your doctor immediately.

If you stop taking Pilesia
Take Pilesia for the entire period recommended by your doctor. Do not stop treatment unless instructed by your doctor. Your doctor may gradually reduce the dose to prevent seizures (epileptic seizures) from recurring or worsening.

If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
A small number of patients treated with antiepileptic medicines have had thoughts about harming themselves or taking their own life. If at any time you experience such thoughts, contact your doctor immediately.

Very common (may affect more than 1 in 10 people):

• dizziness
• feeling sleepy (lethargy or drowsiness)

Common (may affect up to 1 in 10 people):

• reduced or increased appetite, weight gain
• aggression, anger, irritability, anxiety, or confusion
• difficulty walking or other balance problems [ataxia (loss of muscular coordination), gait abnormality, balance disorder]
• slowness of speech (dysarthria)
• blurred vision or double vision (diplopia)
• sensation of dizziness (vertigo)
• nausea
• back pain
• feeling very tired (fatigue)
• fall

Uncommon (may affect up to 1 in 100 people):

• thoughts of self-harm or suicide (suicidal thoughts), suicide attempt
• hallucinations (seeing, hearing or perceiving things that do not exist)
• abnormal thinking and/or loss of contact with reality (psychotic disorder)

Not known (frequency cannot be estimated from the available data):

• Drug reaction with eosinophilia and systemic symptoms, also known as DRESS or drug hypersensitivity syndrome: widespread rash, elevated body temperature, increased liver enzymes, blood abnormalities (eosinophilia), swollen lymph nodes, and involvement of other body organs.
• Stevens-Johnson syndrome (SJS). This serious skin rash may appear as red "target-like" spots or circular patches, often with central blisters, usually on the trunk; skin peeling, mouth ulcers, and sores in the throat, nose, genitals, and eyes. It may be preceded by fever and flu-like symptoms.

Stop taking perampanel if you develop any of these symptoms and contact your doctor or seek immediate medical help. See also section 2.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Pilesia

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister. The expiry date refers to the
last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Pilesia contains
The active substance is perampanel.
Pilesia 2 mg film-coated tablets
Each film-coated tablet contains 2 mg of perampanel.
Pilesia 4 mg film-coated tablets
Each film-coated tablet contains 4 mg of perampanel.
Pilesia 6 mg film-coated tablets
Each film-coated tablet contains 6 mg of perampanel.
Pilesia 8 mg film-coated tablets
Each film-coated tablet contains 8 mg of perampanel.
Pilesia 10 mg film-coated tablets
Each film-coated tablet contains 10 mg of perampanel.
Pilesia 12 mg film-coated tablets
Each film-coated tablet contains 12 mg of perampanel.

The other components are:
Tablet core: lactose monohydrate, microcrystalline cellulose, povidone K30, low-substituted hydroxypropylcellulose, crospovidone (type A), magnesium stearate.

Tablet coating:
Pilesia 2 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, yellow iron oxide (E172), red iron oxide (E172).
Pilesia 4 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, red iron oxide (E172).
Pilesia 6 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, red iron oxide (E172).
Pilesia 8 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, indigo carmine aluminium lake (E132), red iron oxide (E172).
Pilesia 10 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, indigo carmine aluminium lake (E132), yellow iron oxide (E172).
Pilesia 12 mg film-coated tablets: polyvinyl alcohol (partially hydrolysed), titanium dioxide (E171), macrogol 4000, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Pilesia and contents of the pack
Pilesia 2 mg film-coated tablets are beige, round, biconvex film-coated tablets marked with "TV" on one side and "W2" on the other side, available in blisters containing 7 tablets.
Pilesia 4 mg film-coated tablets are pink, round, biconvex film-coated tablets marked with "TV" on one side and "W4" on the other side, available in blisters containing 28 tablets.
Pilesia 6 mg film-coated tablets are pink, round, biconvex film-coated tablets marked with "TV" on one side and "W6" on the other side, available in blisters containing 28 tablets.
Pilesia 8 mg film-coated tablets are purple, round, biconvex film-coated tablets marked with "TV" on one side and "W8" on the other side, available in blisters containing 28 tablets.
Pilesia 10 mg film-coated tablets are green, round, biconvex film-coated tablets marked with "TV" on one side and "W0" on the other side, available in blisters containing 28 tablets.
Pilesia 12 mg film-coated tablets are blue, round, biconvex film-coated tablets marked with "TV" on one side and "W1" on the other side, available in blisters containing 28 tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder
Farmitalia S.r.l.
Via Pinciana 25
00198 Rome
Italy

Manufacturer
Pliva Hrvatska d.o.o.
Prilaz baruna Filipovica 25
Zagreb 10000
Croatia

This medicinal product is authorised in the European Economic Area countries under the following names:
Germany: Pilesia 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, 12 mg Filmtabletten
Italy: Pilesia